The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
- Company
- Instrumentation Laboratory
- Recall Initiated
- December 11, 2025
- Posted
- January 15, 2026
- Recall Number
- Z-1095-2026
- Quantity
- 7,720 units
- Firm Location
- Bedford, MA
Reason for Recall
Potential for microbial contamination.
Distribution
Worldwide - US Nationwide distribution in the states of CA, FL, IL, MN, MS, NE, OH, TX, WI and the countries of Belgium, Netherlands, Luxembourg, Switzerland, China, Hong Kong, Israel, Italy, South Korea, Lithuania, Macao, Malaysia, Philippines, Qatar, Romania, Turkey, Kosovo.
Lot / Code Info
Part Number: 0020006800. UDI-DI: 08426950078920. Lot Number: N1136730. Expiration Date 12/31/2025.
Root Cause
Under Investigation by firm
Action Taken
Werfen notified consignees on about 12/11/2025 via URGENT MEDICAL DEVICE RECALL letter. Consignees were instructed to check inventory for affected lots and destroy any on hand, document any destruction on the provided Urgent Mandatory Tracking Form, inform all laboratory personnel of the notification, forward the notification to all affected departments and locations within each facility, retain a copy of the notification for records, and complete and return the Mandatory Response Tracking Form provided.